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PENTOXIFYLLINE 400 mg Tablet, Extended Release, 60-count

by Bryant Ranch Prepack · 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2910-2)
NDC 63629-2910-02
🏷️ FDA NDC (as labeled) 63629-2910-2 billing pads the package segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.3020/unit — full pricing hub ↓
Also comes in: 30 tablets 63629-2910-01 90 tablets 63629-2910-03
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 63629-2910-2
Product NDC 63629-2910
11-digit billing NDC 63629291002
NCPDP billing unit EA — each (per item)
RxCUI 312301
UNII SD6QCT3TSU
Application # ANDA075191
SPL Set ID 84816505-9253-41cf-8894-2b2d0e4aff67
Established class (EPC) Blood Viscosity Reducer
Physiologic effect Hematologic Activity Alteration
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1999-06-10
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance PENTOXIFYLLINE
GPI-14 85200010000410
GPI class Pentoxifylline ER
GCN Seq No 006573
GCN 11800
HICL code 002819
Ingredient (HICL) Pentoxifylline
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9S
Therapeutic class — specific (HIC3) Hemorrheologic Agents
AHFS code 20:24.00.00
AHFS class Hemorrheologic Agents
FDB label name PENTOXIFYLLINE ER 400 MG TAB
FDB brand name Pentoxifylline
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63629-2910-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 63629-2910-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Blood Viscosity Reducer class.

Pharmacologic class Blood Viscosity Reducer
Drug family (ATC) Purine derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderAPOTEX INC
FDA applicationANDA075191 (ANDA)
Labeler code63629
First marketedJun 1999
Product typeHuman Prescription Drug
Portfolio4,434 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PENTOXIFYLLINE ER 400 MG TAB Ingredient Pentoxifylline
📗 Our plain-language guide HelloPharmacist
  • Pentoxifylline helps your blood flow more easily through the narrowed arteries in your legs. It makes your blood less thick and your red blood cells more flexible, so more oxygen c...
  • What exactly does pentoxifylline do for my legs?
  • You might start to notice some improvement in your walking ability within 2 to 4 weeks, but it's recommended to keep taking it for at least 8 weeks to get the full benefit. Studies...
  • How long will it take before I notice it working?
📖 Read our full Pentoxifylline guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeOval
ImprintAPO;033
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3020 $18.12 / 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pentoxifylline 400 mg 00904-5448-61 Major 1 tablet $0.230 AB Availability likely —
Pentoxifylline 400 mg 16571-0856-01 Rising 100 tablets $0.230 AB Availability likely —
Pentoxifylline 400 mg 60505-0033-06 Apotex 100 tablets $0.230 AB Availability likely —
Pentoxifylline 400 mg 70954-0668-10 ANI 100 tablets $0.230 AB Availability likely —
Pentoxifylline 400 mg 00615-8511-39 NCS 30 tablets — AB FDA listed —
Pentoxifylline 400 mgthis 63629-2910-02 Bryant 60 tablets — AB FDA listed —
Pentoxifylline 400 mg 71335-2586-01 Bryant 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
1999
On the market since
Jun 1999
📍
2026
Currently FDA-listed
27 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Pentoxifylline — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Pentoxifylline. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.3M
Claims incl. refills
82.5K
Beneficiaries
52.3K
Spend / beneficiary
$63.04
Spend / claim
$39.97
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PENTOXIFYLLINE — the ingredient across all brands.

Top reported reactions

Fatigue457
Diarrhoea431
Dyspnoea405
Fall376
Dizziness371
Nausea371
Headache358

Age at onset

Neonate10
Infant6
Child6
Adolescent3
Adult274
Elderly593

Reporter sex

4,300 reports
Male · 45%
Female · 54%
Unknown · 0%

Serious outcomes

Hospitalization1,651
Death746
Life-threatening184
Disabling146
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 309 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63629-2910-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2910-1) 2005-08-09 Active
63629-2910-02 You're viewing this 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2910-2) 2023-03-03 Active
63629-2910-03 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2910-3) 2023-03-03 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63629-2910-02?
NDC 63629-2910-02 is a 60-count package — 60 tablet, extended release in 1 bottle.
What is the difference between NDC 63629-2910-02 and NDC 63629-2910-01?
Both are PENTOXIFYLLINE 400 mg Tablet, Extended Release — the drug itself is identical. NDC 63629-2910-02 is the 60-count package, while NDC 63629-2910-01 is the 30 tablets package.
What NDC number is used to bill for this package of PENTOXIFYLLINE 400 mg Tablet, Extended Release?
Bill NDC 63629-2910-02 — the 11-digit billing format is 63629291002. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 63629-2910-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63629-2910-02, written without dashes as 63629291002. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63629-2910-02, the first segment (63629) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2910) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (63629-2910-01), 90 tablets (63629-2910-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 56 words ▾

INDICATIONS AND USAGE Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.

⏱️ Dosage and Administration 135 words ▾

DOSAGE AND ADMINISTRATION The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals. While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.

Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.

In patients with severe renal impairment (creatinine clearance below 30 mL/min) reduce dose to 400 mg once a day. Dosing information cannot be provided for patients with hepatic impairment.

⛔ Contraindications 33 words ▾

CONTRAINDICATIONS Pentoxifylline should not be used in patients with recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Clinical trials were conducted using either extended-release pentoxifylline tablets for up to 60 weeks or immediate-release pentoxifylline capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200 to 400 mg tid. The table summarizes the incidence (in percent) of adverse reactions considered drug related, as well as the numbers of patients who received extended-release pentoxifylline tablets, immediate-release pentoxifylline capsules, or the corresponding placebos.

The incidence of adverse reactions was higher in the capsule studies (where dose related increases were seen in digestive and nervous system side effects) than in the tablet studies. Studies with the capsule include domestic experience, whereas studies with the extended-release tablets were conducted outside the U.S. The table indicates that in the tablet studies few patients discontinued because of adverse effects.

INCIDENCE (%) OF SIDE EFFECTS Extended-Release Tables Immediate-Release Capsules Commercially Available Used Only For Controlled Clinical Trials Pentoxifylline Placebo Pentoxifylline Placebo (Number of Patients at Risk) (321) (128) (177) (138) Discontinued for Side Effect 3.1 0 9.6

7.2CARDIOVASCULAR SYSTEM Angina/Chest Pain 0.3 - 1.1

2.2Arrhythmia/Palpitation - - 1.7

0.7Flushing - - 2.3

0.7DIGESTIVE SYSTEM Abdominal Discomfort - - 4.0

1.4Belching/Flatus/Bloating 0.6 - 9.0

3.6Diarrhea - - 3.4

2.9Dyspepsia 2.8 4.7 9.6

2.9Nausea 2.2 0.8 28.8

8.7Vomiting 1.2 - 4.5

0.7NERVOUS SYSTEM Agitation/Nervousness - - 1.7

0.7Dizziness 1.9 3.1 11.9

4.3Drowsiness - - 1.1

5.8Headache 1.2 1.6 6.2

5.8Insomnia - - 2.3

2.2Tremor 0.3 0.8 - - Blurred Vision - - 2.3

1.4Pentoxifylline has been marketed in Europe and elsewhere since 1972. In addition to the above symptoms, the following have been reported spontaneously since marketing or occurred in other clinical trials with an incidence of less than 1%; the causal relationship was uncertain: Cardiovascular - dyspnea, edema, hypotension. Digestive - anorexia, cholecystitis, constipation, dry mouth/thirst.

Nervous - anxiety, confusion, depression, seizures, aseptic meningitis. Respiratory - epistaxis, flu-like symptoms, laryngitis, nasal congestion. Skin and Appendages - brittle fingernails, pruritus, rash, urticaria, angioedema.

Special Senses - blurred vision, conjunctivitis, earache, scotoma. Miscellaneous - bad taste, excessive salivation, leukopenia, malaise, sore throat/swollen neck glands, weight change. A few rare events have been reported spontaneously worldwide since marketing in 1972.

Although they occurred under circumstances in which a causal relationship with pentoxifylline could not be established, they are listed to serve as information for physicians. Cardiovascular - angina, arrhythmia, tachycardia. Digestive - hepatitis, jaundice, cholestasis, increased liver enzymes; and Hemic and Lymphatic - decreased serum fibrinogen, pancytopenia, aplastic anemia, leukemia, purpura, thrombocytopenia.

Immune system disorders - anaphylactic reaction, anaphylactoid reaction, anaphylactic shock.

🔄 Drug Interactions 220 words ▾

Drug Interactions Bleeding has been reported in patients treated with pentoxifylline with or without concomitant NSAIDs, anticoagulants, or platelet aggregation inhibitors. Increased prothrombin time has been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.

Concomitant administration of pentoxifylline and theophylline-containing drugs leads to increased theophylline levels and theophylline toxicity in some individuals. Monitor theophylline levels when starting pentoxifylline or changing dose. Concomitant administration of strong CYP1A2 inhibitors (including e.g. ciprofloxacin or fluvoxamine) may increase the exposure to pentoxifylline (see ADVERSE REACTIONS ).

Pentoxifylline has been used concurrently with antihypertensive drugs, beta blockers, digitalis, diuretics, and antiarrhythmics, without observed problems. Small decreases in blood pressure have been observed in some patients treated with pentoxifylline plus nifedipine or captopril; periodic systemic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy. If indicated, dosage of the antihypertensive agents should be reduced.

Postmarketing cases of increased anticoagulant activity have been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed. Concomitant administration with cimetidine is reported to increase the average steady state plasma concentration of pentoxifylline (~25%) and the Metabolite I (~30%).

🤰 Pregnancy 197 words ▾

Pregnancy Category C. Teratogenicity studies have been performed in rats and rabbits using oral doses up to 576 and 264 mg/kg, respectively. On a weight basis, these doses are 24 and 11 times the maximum recommended human daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the MRHD.

No evidence of fetal malformation was observed. Increased resorption was seen in rats of the 576 mg/kg group. There are no adequate and well controlled studies in pregnant women.

Pentoxifylline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Category C. Teratogenicity studies have been performed in rats and rabbits using oral doses up to 576 and 264 mg/kg, respectively. On a weight basis, these doses are 24 and 11 times the maximum recommended human daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the MRHD.

No evidence of fetal malformation was observed. Increased resorption was seen in rats of the 576 mg/kg group. There are no adequate and well controlled studies in pregnant women.

Pentoxifylline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 108 words ▾

OVERDOSAGE Overdosage with pentoxifylline has been reported in pediatric patients and adults. Symptoms appear to be dose related. A report from a poison control center on 44 patients taking overdoses of enteric-coated pentoxifylline extended-release tablets noted that symptoms usually occurred 4 to 5 hours after ingestion and lasted about 12 hours.

The highest amount ingested was 80 mg/kg; flushing, hypotension, convulsions, somnolence, loss of consciousness, fever, and agitation occurred. All patients recovered. In addition to symptomatic treatment and gastric lavage, special attention must be given to supporting respiration, maintaining systemic blood pressure, and controlling convulsions.

Activated charcoal has been used to absorb pentoxifylline in patients who have overdosed.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mode of Action Pentoxifylline and its metabolites improve the flow properties of blood by decreasing its viscosity. In patients with chronic peripheral arterial disease, this increases blood flow to the affected microcirculation and enhances tissue oxygenation. The precise mode of action of pentoxifylline and the sequence of events leading to clinical improvement are still to be defined.

Pentoxifylline administration has been shown to produce dose-related hemorrheologic effects, lowering blood viscosity, and improving erythrocyte flexibility. Leukocyte properties of hemorrheologic importance have been modified in animal and in vitro human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation.

Tissue oxygen levels have been shown to be significantly increased by therapeutic doses of pentoxifylline in patients with peripheral arterial disease. Pharmacokinetics and Metabolism After oral administration in aqueous solution pentoxifylline is almost completely absorbed. It undergoes a first-pass effect and the various metabolites appear in plasma very soon after dosing.

Peak plasma levels of the parent compound and its metabolites are reached within 1 hour. The major metabolites are Metabolite I (1-[5-hydroxyhexyl]-3,7-dimethylxanthine) and Metabolite V (1-[3-carboxypropyl]-3,7-dimethylxanthine), and plasma levels of these metabolites are 5 and 8 times greater, respectively, than pentoxifylline. Following oral administration of aqueous solutions containing 100 to 400 mg of pentoxifylline, the pharmacokinetics of the parent compound and Metabolite I are dose-related and not proportional (non-linear), with half-life and area under the blood-level time curve (AUC) increasing with dose.

The elimination kinetics of Metabolite V are not dose-dependent. The apparent plasma half-life of pentoxifylline varies from 0.4 to 0.8 hours and the apparent plasma half-lives of its metabolites vary from 1 to 1.6 hours. There is no evidence of accumulation or enzyme induction (Cytochrome P450) following multiple oral doses.

Excretion is almost totally urinary; the main biotransformation product is Metabolite V. Essentially no parent drug is found in the urine. Despite large variations in plasma levels of parent compound and its metabolites, the urinary recovery of Metabolite V is consistent and shows dose proportionality.

Less than 4% of the administered dose is recovered in feces. Food intake shortly before dosing delays absorption of an immediate-release dosage form but does not affect total absorption. The pentoxifylline AUC was increased and elimination rate decreased in an older population (60 to 68 years, n=6) compared to younger individuals (22 to 30 years, n=6) (see PRECAUTIONS , Geriatric Use ).

After administration of the 400 mg extended-release pentoxifylline tablet, plasma levels of the parent compound and its metabolites reach their maximum within 2 to 4 hours and remain constant over an extended period of time. Coadministration of pentoxifylline extended-release tablets with meals resulted in an increase in mean AUC and C max of about 1.1 and 1.3 fold for pentoxifylline, respectively. C max for Metabolite I also increased about 1.2 fold.

The extended release of pentoxifylline from the tablet eliminates peaks and troughs in plasma levels for improved gastrointestinal tolerance. Patients with Hepatic Impairment In patients with mild to moderate liver impairment AUC and C max of pentoxifylline increased 6.5 and 7.5 fold, respectively, after a single 400 mg dose of pentoxifylline extended-release tablet AUC and C max of the active Metabolite I also increased 6.9 and 8.2 fold, respectively, in hepatic impaired subjects. Pentoxifylline extended-release tablet has not been studied in patients with severe hepatic failure.

Patients with Renal Impairment In patients with mild, moderate, or severe renal impairment the exposure to pentoxifylline and its active…

📦 How Supplied / Storage and Handling 82 words ▾

HOW SUPPLIED Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side NDC: 63629-2910-1: 30 Tablets in a BOTTLE NDC: 63629-2910-2: 60 Tablets in a BOTTLE NDC: 63629-2910-3: 90 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.

Burbank, CA 91504

📋 Description 99 words ▾

DESCRIPTION Pentoxifylline extended-release tablets, USP for oral administration contain 400 mg of the active drug and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide in an extended-release formulation. Pentoxifylline is a tri-substituted xanthine derivative designated chemically as 3,7-Dihydro-3,7-dimethyl-1-(5-oxohexyl)-1H-purine-2,6-dione that, unlike theophylline, is a hemorrheologic agent, i.e., an agent that affects blood viscosity.

Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The molecular formula is C 13 H 18 N 4 O 3 and its molecular weight is 278.31. The chemical structure is: USP Dissolution Test 9

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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